Clinical Study to Evaluate the Pharmacokinetics, Safety and Tolerability of DA-2803 in Healthy Subjects

Hepatitis B Clinical Trial

Official title:

A Randomized, Open-label, Single-dose, 2x2 Crossover Study to Compare the Safety/Tolerability and Pharmacokinetics Between and DA-2803 and Vemlidy® After Meal in Healthy Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04906109
• Other study ID #: DA2803_BE_I
• Status: Completed
• Phase: Phase 1
• Start date: July 12, 2021
• Est. completion date: October 5, 2021

Study information

• Verified date: June 2022
• Source: Dong-A ST Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is an open-label, randomized, single dose, crossover study to evaluate the pharmacokinetics, safety and tolerability of DA-2803 in healthy subjects

Description:

To healthy subjects of ninety-six (96), following treatments are administered dosing in each period and wash-out period is a minimum of 14 days. Reference drug: Vemlidy Tab. / Test drug: DA-2803 Tab. Pharmacokinetic blood samples are collected up to 72hrs. The pharmacokinetic characteristics and safety are assessed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: October 5, 2021
• Est. primary completion date: October 5, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 45 Years

Eligibility

Inclusion Criteria:

• Healthy male volunteers, aged between = 19 and = 45 years old at the time of screening.
• Calculated body mass index (BMI) of = 18.0 and = 28.0 kg/m2
• BMI = Weight(kg)/ Height(m)2
• Individuals who agreed proper contraception during the study and did consent to not donation of sperm and ovum before the termination of study
• Individuals who voluntary decide to participate and agrees in writing to comply with the precautions after hearing and fully understanding the detailed explanation of this clinical trial

Exclusion Criteria:

• History or presence of clinically significant and sever active cardiovascular, respiratory, hepatobiliary, renal, hematological, gastrointestinal, endocrine, immune, dermatologic, neurologic, or psychiatric disorder.
• Any medical history that may affect drug absorption, distribution, metabolism and excretion.
• Individuals who had history of hypersensitivity to Investigational drugs, derivative drugs or others drugs(aspirin and antibiotics etc.)
• Any clinically significant chronic medical illness.
• Any genetic disease including galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
• Individuals with one of the following laboratory test results in screening.
• AST, ALT > UNL (upper normal limit) x 1.5
• Creatinine clearance = 60 mL/min
• Positive test results at HBs Ag, anti-HCV Ab, anti-HIV Ab, VDRL.
• Use of any prescription drugs and herbal preparations within 14 days prior to study drug administration and use of over-the-counter medications within 10 days prior to study drug administration.
• Individuals who cannot eat standard meal provided from clinical trial center.
• Donation of blood within 60 days prior to study drug administration or apheresis within 30 days prior to the first IP administration.
• Individuals who had received a blood transfusion within 60 days prior to study drug administration.
• Exposure to any investigational drug within 6 months prior to the first IP administration.
• Individuals taking any drugs inducing or inhibiting drug metabolizing enzymes including barbiturates within 30 days prior to the first IP administration.
• Individuals who had drinking (alcohol > 21unit/week) within 14 days prior to screening.
• Heavy smoking (more than 10 cigarettes/day) within 14 days prior to screening.
• Subjects having been deemed inappropriate for the trial as determined by the investigator.

Related Conditions & MeSH terms

• Hepatitis B

Intervention

Drug:
• Vemlidy Tab
1T
• DA-2803 Tab
1T

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul	Songpa-gu

Sponsors (1)

Lead Sponsor	Collaborator
Dong-A ST Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUCt of DA-2803, Vemlidy	Area under the DA-2803/Vemlidy concentration in blood-time curve from zero to final	pre-dose(0 hour), 0.08, 0.17, 0.33, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72 hour
Primary	Cmax of DA-2803, Vemlidy	The maximum DA-2803/Vemlidy concentration in blood sampling time t	pre-dose(0 hour), 0.08, 0.17, 0.33, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72 hour